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Quality of the estimate. December, p. 47 - Health Care Compliance ...

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Regulatory compliance for research in an academic medical center<br />

...continued from page 37<br />

In addition to overall compliance<br />

program effectiveness reviews,<br />

organizations can benefit from<br />

targeted monitoring by independent<br />

experts. For organizations<br />

that have detected violations, <strong>the</strong><br />

2010 amendment to <strong>the</strong> Federal<br />

Sentencing Guidelines permits a<br />

health care organization to decide<br />

whe<strong>the</strong>r to retain an independent<br />

monitor to ensure that changes to<br />

<strong>the</strong> compliance program which<br />

were designed to prevent recurrences<br />

have been effectively implemented.<br />

3 This form <strong>of</strong> accountability<br />

will be seen quite favorably<br />

when serious infractions have been<br />

discovered and will demonstrate to<br />

<strong>the</strong> government that <strong>the</strong> organization<br />

is serious about remediating<br />

<strong>the</strong> harm done and preventing<br />

future misconduct.<br />

Having an effective compliance<br />

program not only reduces <strong>the</strong><br />

likelihood <strong>of</strong> fines and penalties<br />

in <strong>the</strong> event <strong>of</strong> a government<br />

investigation, but it protects <strong>the</strong><br />

organization’s public image and<br />

reputation from damage and<br />

fosters trust by investors, patients,<br />

and <strong>the</strong> community. n<br />

1. United States Sentencing Guidelines,<br />

Chapter 8, Subsection 8A1.2<br />

2. Publication <strong>of</strong> <strong>Compliance</strong> Program Guidance<br />

for Hospitals, Federal Register, Vol.<br />

63, No. 35, Monday, February 23, 1998/<br />

Notices<br />

3. US Sentencing Commission, Amendment<br />

to <strong>the</strong> Sentencing Guidelines at 17-18<br />

(April 30, 2010)<br />

completed per month increased<br />

by 250%. Federal and state<br />

awards increased by more than<br />

200% in three years, and <strong>the</strong><br />

number <strong>of</strong> research projects that<br />

are part <strong>of</strong> <strong>the</strong> residency training<br />

programs increased 375%.<br />

These increases occurred as a<br />

consequence <strong>of</strong> <strong>the</strong> institution’s<br />

commitment to growth in capacity<br />

and resources for <strong>the</strong> Department<br />

<strong>of</strong> Research. A strategy was<br />

developed for systems, policies,<br />

and processes that required<br />

prioritization in development and<br />

implementation. Also, a focus<br />

was placed on education before<br />

regulation to identify appropriate<br />

growth <strong>of</strong> research administration<br />

functions. The steps outlined in<br />

this article reflect <strong>the</strong> experience<br />

<strong>of</strong> this institution and Department<br />

<strong>of</strong> Research, but should<br />

have applicability to o<strong>the</strong>r standalone<br />

academic medical centers. n<br />

1. Elliott C. Kulakowski and Lynne U. Chronister:<br />

Research Administration and Management.<br />

Jones and Bartlett Publishers, 2006.<br />

2. Goldenberg NA, Spyropoulos AC,<br />

Halperin JL, et al: Antithrombotic Trials<br />

Leadership and Steering Group. Improving<br />

academic leadership and oversight in<br />

large industry-sponsored clinical trials:<br />

<strong>the</strong> ARO-CRO model. Blood; 2011 Feb<br />

17;117(7):2089-92.<br />

3. Campbell, JM: Assessing and managing<br />

research compliance risks in <strong>the</strong> health care<br />

setting. <strong>Compliance</strong> Today, 12(11):20-25, 2010.<br />

4. Epic<strong>Care</strong> EMR is a product <strong>of</strong> Epic. More<br />

information at http://www.epic.com/<br />

s<strong>of</strong>tware-ambulatory.php<br />

<strong>Health</strong> <strong>Care</strong> Auditing &<br />

Monitoring Tools<br />

More than 100 sample<br />

policies, procedures,<br />

guidelines, and forms to<br />

enhance your compliance<br />

auditing and monitoring<br />

efforts. Updated<br />

biannually with new tools.<br />

For more information,<br />

visit www.hcca-info.org/books, or<br />

call 888-580-8373.<br />

<strong>Health</strong> <strong>Care</strong> <strong>Compliance</strong> Association • 888-580-8373 • www.hcca-info.org<br />

<strong>December</strong> 2011<br />

55

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